CERTIFICATION/DISCLOSURE FORM - AdventHealth
|Please complete all of the information below and retain a copy of this form for your records. |
|*Note: Each investigator on the study, principal and sub-investigator(s), must submit a financial disclosure form |
|1. Study Name: |
|2. Protocol number: |
|Investigator Name: |
|Institution Name (if applicable): |
|5. Address: |
|6. Telephone: |7. Fax: |
|8. Indicate by marking YES or NO if any of the financial interests or arrangements of concern to FDA (and described below) apply to you, your spouse, or |
|dependent children: |
| YES NO | |
| |Financial arrangements whereby the value of the compensation could be influenced by the outcome of the study. This could include, |
| |for example, compensation that is explicitly greater for a favorable outcome, or compensation to the investigator in the form of an|
| |equity interest in the sponsor or in the form of compensation tied to sales of the product, such as a royalty interest. |
| |If yes, please describe: |
| YES NO |Significant payments of other sorts from the sponsor, excluding the costs of conducting the study or other clinical studies. This |
| |could include, for example, payments made to the investigator or the institution to support activities that have a monetary value |
| |greater than $25,000 U.S. (i.e. a grant to fund ongoing research, compensation in the form of equipment, or retainers for ongoing |
| |consultation or honoraria). |
| |If yes, please describe: |
| YES NO |A proprietary or financial interest in the test product such as a patent, trademark, copyright, or licensing agreement. |
| |If yes, please describe: |
| YES NO |A significant equity interest in the sponsor of the study. This would include, for example, any ownership interest, stock options,|
| |or other financial interest whose value cannot be readily determined through reference to public prices, or an equity interest in a|
| |publicly traded company exceeding $50,000 U.S. |
| |If yes, please describe: |
|or |
| I hereby certify that none of the financial interests or arrangements listed above exist for myself, my spouse, or my dependent children. |
|In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information provided on this form is, to the best of my knowledge and belief, true, correct, |
|and complete. Furthermore, if my financial interests and arrangements, or those of my spouse and dependent children, change from the information provided above|
|during the course of the study or within one year after the last patient has completed the study as specified in the protocol, I will notify the sponsor |
|promptly. |
|9. Signature: |10. Date: |
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